• The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods and carries out a range of assessment and monitoring activities – click here for more info.
• The Pharmaceutical Benefits Scheme (PBS) is the Australian government system that subsidises medicines’ costs – more info here.
• The Pharmaceutical Benefits Advisory Committee (PBAC):¹
  • is an “independent expert body”
  • has the primary role of recommending “new medicines for listing on the PBS”
  • can be doing reimbursement and assessment processes in parallel while a product is going through TGA processes
  • more info.
• The TGA does not:
  • make recommendations/decisions regarding the PBS
  • regulate clinical practice.
• Although the TGA is the national body for regulating medicines, each state and territory self-regulates under the general principles established by the TGA and has its own legislative framework regarding Schedule 8 drugs.
  • State/territory-specific requirements and PBS authority requirements often both apply to a prescriber.
• More detailed overview information on medicine regulation in Australia (including TGA, Australian Register of Therapeutic Goods, PBS, and Poisons Standard) here.

• “Legal or pharmaceutical opioids ... are responsible for far more deaths and poisoning hospitalisations than illegal opioids (such as heroin). Every day in Australia, nearly 150 hospitalisations and 14 emergency department presentations involve opioid harm, and three people die from drug-induced deaths involving opioid use.”²(p.viii)
• “In this meta-analysis of RCTs [randomised clinical trials] of patients with chronic noncancer pain, evidence from high-quality studies showed that opioid use was associated with statistically significant but small improvements in pain and physical functioning, and increased risk of vomiting compared with placebo. Comparisons of opioids with nonopioid alternatives suggested that the benefit for pain and functioning may be similar, although the evidence was from studies of only low to moderate quality.”³
• Opioid prescribing has grown despite the absence of evidence of the benefits of long-term opioid use.⁴
• “There is a critical lack of high‐quality evidence regarding how well high‐dose opioids work for the management of chronic noncancer pain in adults, and regarding the presence and severity of adverse events. No evidence‐based argument can be made on the use of high‐dose opioids, i.e. 200 mg morphine equivalent or more daily, in clinical practice.”⁵
• Opioids “… carry significant risk of harm, even when used as prescribed.”⁶
• “The changes to opioid indications align with the latest scientific evidence regarding opioid prescribing and aim to reduce the risk associated with their use while ensuring adequate pain management.”⁶
• Guidelines for opioid use in chronic noncancer pain (CNCP) in general practice by The Royal Australian College of General Practitioners include the following.⁷

For accountable prescribing in managing CNCP, GPs should:

• undertake a complete biopsychosocial assessment of the patient with pain
• optimise non-drug therapies, and optimise non-opioid therapies as the primary interventions of care.



Opioids for CNCP should be reserved for selected patients with moderate or severe pain that has not responded to other therapies and that significantly affects function or quality of life. If primary interventions fail or are suboptimal, opioid therapies may be considered. GPs should share the decision-making process with the patient, and if opioid therapy is considered, there should be:

• a patient selection/exclusion process before a therapeutic opioid trial
• formal care planning based on specific goals and risks
• an opioid trial, which is undertaken to determine a patient’s response to opioid therapy. This trial includes the selection of an appropriate opioid, formal measures of analgesia and functionality, a trial of dose reduction, and a drug cessation plan if the trial fails
• an ongoing assessment and evaluation by the accountable prescriber if the trial shows opioid benefit
• opioid tapering and cessation if suboptimal results or aberrant behaviour occurs.



Long-term use should be uncommon, undertaken with caution and based on consideration of the likely risks and benefits of opioids. Intermittent use is preferable.

• The Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine is updating their opioid prescribing guidelines in parallel with the regulatory changes.
• The TGA is supporting the Australian Commission of Safety and Quality in Health Care to develop a national opioid analgesic stewardship program and associated clinical care standards.
  This program will:
• improve and build upon current frameworks and standards
• identify new best practice models to allow for consistent adoption nationally.

• Targeted consultation with key groups started early 2018; followed by public consultation.
  • “ … 98 submissions were received with feedback indicating strong and consistent support from all stakeholders for a regulatory response.”⁸
• The TGA then established the Opioid Regulatory Advisory Group (ORAG) which included representatives from a range of organisations, to provide independent, expert advice.
  • The Royal Australian College of General Practitioners
  • Australian and New Zealand Society of Palliative Medicine
  • Painaustralia
  • The Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine
  • Royal Melbourne Hospital
  • Australian Medical Association
  • Palliative Care Australia
  • University of Western Australia
  • The Royal Australasian College of Physicians
  • Australian Commission on Safety and Quality in Health Care
  • Tasmanian Health Services
  • Society of Hospital Pharmacists of Australia
  • Pharmaceutical Society of Australia.
• The ORAG “… strongly supported the proposed options and provided advice on how best to implement them”.⁸
• Click here for more information on the consultation process, e.g. submissions received and steps involved.

• Opioid resources, 9 November 2020
  • Note the TGA links to Painaustralia’s national directory – for help finding multidisciplinary pain management programs
• Opioids: boxed warning and class statements, 19 December 2019
• Learn about the intentions and considerations leading to the PBAC recommendations in its Public summary documents
  • 2019 TGA summary documents relating to prescription opioid regulatory reforms
• Subscribe to PBS news and updates
• Form to apply for a PBS-subsidised treatment with opioids

Note: Pharmaceutical Benefits Scheme authority and state/territory health department approval to prescribe Schedule 8 opioids may both be required.

• The requirement for a permit from your state/territory health department is separate and additional to the requirement of authority to prescribe certain medications under the PBS (which relates to prescription funding).
• MDA National’s Prescribing opioids on-demand e-learning activity has detailed information on lawful prescribing around Australia.

Find information about permits, treatment programs and legal issues in your jurisdiction:

• Australian Capital Territory
  • 02 5124 9208, hps@act.gov.au
  • Pharmaceutical services
• New South Wales
  • General inquiries = 02 9391 9944, MOH-PharmaceuticalServices@health.nsw.gov.au
  • Opioid Treatment Program inquiries = 02 9424 5921
  • Authority inquiries = 02 9424 5923
  • Pharmaceutical services
  • NSW legal requirements for an authority to prescribe drugs of addiction
  • Application forms for authority to prescribe
  • Prescribing a Schedule 8 opioid or benzodiazepine
• Northern Territory
  • 1800 812 804
  • Medical practitioners and schedule 8 medicines
• Queensland
  • 13 78 46
  • Drugs of dependence
• South Australia
  • 1300 652 584, HealthDrugsofDependenceUnit@sa.gov.au
  • Prescribing drugs of dependence
  • Drugs of dependence
• Tasmania
  • 1300 135 513, www.dhhs.tas.gov.au/psbtas
  • Licence application forms
• Victoria
  • 1300 364 545; dpcs@dhhs.vic.gov.au
  • Medical practitioners and lawful treatment 
  • Medicines and poisons
  • Online forms – drugs and poisons regulation
  • Also note SafeScript requirements
• Western Australia
  • 08 9222 4424, MPRB@health.wa.gov.au
  • Opioids, benzodiazepines and other Schedule 8 medicines

• DORA – real time prescription monitoring
  • Tasmania, 03 6166 0400
  • ACT
• WA Schedule 8 Medicines Prescriber Information Service for “advice on a patient’s prescribing and dispensing history” – 08 9222 4424
• Queensland enquiry service about Schedule 8 medicines a person has obtained – 13 78 46
• Prescription Shopping Information Service, national
  • 1800 631 181
  • Prescription Shopping Programme
  • Accessing Prescription Shopping Information Service
  • How to register for an Individual [PRODA] account
• Victoria – per note in section above – Safescript real-time prescribing and dispensing records for particular medicines

• Faculty of Pain Medicine ANZCA, Better Pain Prescribing. Clarity and confidence in opioid management
• NPS MedicineWise, Opioids: redefining ‘doing well’ on opioids clinical e-audit
• Australian College of Rural and Remote Medicine, Reducing opioid harm
• Rural Doctors Association of Australia, Reducing opioid harm
• Australian Government
• Clinician information sheet on opioid analgesic tapering
• Opioid resources
• More detail on prescription opioid regulatory changes overseen by TGA

• Opioid PBS authority application forms. Some authority applications can be submitted online in real time – access here.
• Public summary document – TGA Prescription Opioid Regulatory Reforms
• Request an authority using Online PBS Authorities in HPOS
• National Pain Services Directory
• Detailed information about each PBAC recommendation
• Subscribe to PBS news and updates